FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
15025–15048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2022
JETi AIO Peripheral Thrombectomy System
K213565 · QEZ
Walk Vascular, LLC
Cardiovascular · 84d
Cleared Feb 01, 2022
Exeter® X3® RimFit® Cup
K213701 · JDI
Howmedica Osteonics Corp., Dba...
Orthopedic · 69d
Cleared Feb 01, 2022
Home use hair removal device, model: Precise Touch Pro
K213830 · OHT
Iluminage Beauty Co., Limited
General & Plastic Surgery · 55d
Cleared Feb 01, 2022
Permadyne
K220257 · ELW
3M Deutschland GmbH
Dental · 1d
Cleared Jan 31, 2022
Alltest Pregnancy Rapid Combo Test Cassette
K203272 · JHI
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 451d
Cleared Jan 31, 2022
MIS Precision Chevron Bunion System
K211628 · HWC
Relja Innovations, LLC
Orthopedic · 249d
Cleared Jan 31, 2022
Primary Relief
K213188 · NHI
Dyansys, Inc.
Neurology · 124d
Cleared Jan 31, 2022
DIAPLUS Universal
K213401 · KLE
DiaDent Group International
Dental · 105d
Cleared Jan 31, 2022
SKR 3000
K213908 · MQB
Konica Minolta, Inc.
Radiology · 48d
Cleared Jan 31, 2022
8mm Monopolar Curved Scissors
K220023 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 26d
Cleared Jan 28, 2022
syngo.CT Brain Hemorrhage
K203260 · QAS
Siemens Medical Solutions USA, Inc.
Radiology · 449d
Cleared Jan 28, 2022
Platform treatment system
K203395 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 436d
Cleared Jan 28, 2022
Optiflow Oxygen Kit
K211096 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 290d
Cleared Jan 28, 2022
Surgical Masks
K212120 · FXX
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 205d
Cleared Jan 28, 2022
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U,...
K212341 · DTZ
Qura S.R.L
Cardiovascular · 184d
Cleared Jan 28, 2022
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
K212533 · DZE
Institut Straumann AG
Dental · 170d
Cleared Jan 28, 2022
iHealth infrared Ear thermometer PT5
K212598 · FLL
Andon Health Co, Ltd.
General Hospital · 165d
Cleared Jan 28, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack
K212648 · JHX
Ortho-Clinical Diagnostics
Chemistry · 158d
Cleared Jan 28, 2022
SyntheCel Dura Repair
K212943 · GXQ
Synthes USA Products, LLC
Neurology · 135d
Cleared Jan 28, 2022
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
K213082 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 127d
Cleared Jan 28, 2022
STEP-1 PumEtch
K213093 · KLE
Rounding Third, LLC
Dental · 126d
Cleared Jan 28, 2022
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and...
K213142 · LZA
Shen Wei (Usa), Inc.
General Hospital · 123d
Cleared Jan 28, 2022
ShinEvac Smoke Evacuation Pencil
K213317 · GEI
Shining World Health Care Co., Ltd.
General & Plastic Surgery · 116d
Cleared Jan 28, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use With...
K213325 · LZC
Anhui Xinyisheng Medical Technology...
General Hospital · 115d